MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING SL; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	24703
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that balloon detachment occurred.The target lesion was an area of instent restenosis located in the right superficial femoral artery.A 3.5x40x150 (4f) sterling balloon catheter was advanced for dilatation.However, upon deflation of balloon, part of the balloon came off.Subsequently, the piece of the balloon was removed with a snare.The procedure was completed with another balloon.There were no patient complications reported.
Event or Problem Description
It was reported that balloon detachment occurred.The target lesion was an area of instant restenosis located in the right superficial femoral artery.A 3.5x40x150 (4f) sterling balloon catheter was advanced for dilatation.However, upon deflation of balloon, part of the balloon came off.Subsequently, the piece of the balloon was removed with a snare.The procedure was completed with another balloon.There were no patient complications reported.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).D4 lot number: updated from 0024680402 to 0025200218.Device evaluated by mfr: returned product consisted of a sterling balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was a circumferential tear resulting in a complete separation at 134.6cm distal of the strain relief.The inner shaft was separated at the tac weld.In the proximal portion, there was no contrast or blood.In the distal portion, there was contrast and blood in the balloon, and blood in the guidewire lumen.There was an unknown snare device with the complaint device.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: STERLING SL
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10218302
• Report Number: 2134265-2020-08733
• Device Sequence Number: 3656438
• Product Code: DQY
• UDI-Device Identifier: 08714729860235
• UDI-Public: 08714729860235
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K093720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/11/2022
• Device Model Number: 24703
• Device Catalogue Number: 24703
• Device Lot Number: 0025200218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Initial Date Received by Manufacturer: 06/26/2020
• Supplement Date Received by Manufacturer: 08/19/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 08/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR